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CompletedNCT05061121Updated Sep 7, 2022

Effect of Sustained Natural Apophseal Glides and Myofascial Release on Chronic Non-specific Neck Pain

An interventional study of combined effect in Neck Pain, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

The aim of investigator's study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.

Read the detailed description

Neck pain NP is a recognized medical and socioeconomic problem, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services .NP is widely spread in healthcare centers with a prevalence estimation of 288.7 million, in North Africa and the Middle East ranged between 3917.7 to 5022.4 per 100 000 populations in 2017. NP with symptoms duration exceeding 12 weeks is considered chronic.

Individuals who have chronic non-specific neck pain CNSNP have less quality of life, and more pain interference in their life. More over studies showed that patients with CNSNP subjects have poorer postural control than healthy subjects.

Alteration of the proprioception of the neck muscles and joints that play a master role in the cervical joint position and motor control of the head could be the primary cause of CNSNP . Studies have evaluated the effect of different manual techniques in cases of CNSNP checking mainly usefulness and effectiveness of these interventions on this clinical condition. However, there is less evidence in literature investigating the short and mid-term changes of these techniques.

Manual therapy, is a physical treatment primarily used by physical therapists, occupational therapists, manipulative therapy to treat musculoskeletal pain and disability; it is most commonly includes kneading , manipulation of the muscles and mobilization of joints .Many Studies investigating the effectiveness of manual therapies on CNSNP ,proving reduction of spinal excitability and pain sensitivity, enhancement of function and range of motion.

Brian Mulligan techniques are widely used for joint dysfunction by growing number of therapists and are an important addition to the field of Manual Therapy. Literature reveals many and diverse treatment approaches for chronic neck pain. Sustained natural apophyseal glides SNAGs are pain free spinal manual therapy treatment techniques involving concurrent accessory joint gliding and active physiological movement, with overpressure at end range, which are utilized for painful movement restrictions of the spine.

Mulligan's SNAGs is one of the most statistically proved in many studies that manual therapy technique affects proprioception, function, range of motion, pain.

On the other hand, Myofascial release which is a form of soft tissue therapy that is intended to reduce pain and increase mobility in patients that are suffering from chronic pain conditions. Myofascial release has shown effectiveness in reducing mechanical neck pain and in improving functional abilities by freeing restrictions of movement that originate in the soft tissues of the body.

Furthermore, as the focus of most previous studies has been to examine compare mulligan's SNAGs and Myofascial release separately, studies on their combination effects have been largely ignored. Both two techniques have shown efficacy, but since SNAGS and Myofascial release are different mechanisms of action, the time of their effects and their progression could be different.

The aim of investigators' study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.

02

Conditions studied

  • Neck Pain

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Keywords

  • CNSNP
  • SNAGs
  • MFR
03

In context

Neck Pain

1,259 studies on the registry are indexed under Neck Pain; 256 are open to participants now.

This study's enrollment of 59 is above the median of 52 across 1,026 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ranged from 20-45 years
  • Current neck pain
  • Neck pain continued for at least the last 12 week
  • Pain with no obvious organic or pathologic cause.
  • The patients diagnosed as chronic non-specific neck pain through an orthopedic specialist, diagnostic investigations including X rays and MRI failed to show obvious pathological findings

Exclusion criteria

Exclusion Criteria:

  • Irradiated neck pain
  • Neck pain associated with vertigo
  • Osteoporosis
  • Diagnosed psychological disorders
  • Vertebral fractures
  • Tumors
  • Diagnosed metabolic diseases
  • Previous neck surgery
  • Red flags (night pain, severe muscle spasm, loss of
  • involuntary weight, symptom mismatch)
  • Physiotherapeutic treatment continued in the last 3 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    sustained natural apophyseal glides

    Investigate the short- and mid-term effects of Mulligan's SNAGs on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

    Other: combined effect

  • Experimental
    Myofascial release

    Investigate the short- and mid-term effects of Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

    Other: combined effect

  • Experimental
    sustained natural apophyseal glides in addition to myofascial release

    Investigate the short- and mid-term effects of Mulligan's SNAGs combined with Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

    Other: combined effect

Interventions

  • Othercombined effect

    Compare the short- and mid-term effects of Mulligan's SNAGs, Myofascial release, and their combination on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients

06

What researchers measure

Primary outcomes

  1. pain intensity VAS

    visual analogue scale ,The pain VAS is a continuous scale formed of a horizontal (HVAS) or vertical (VVAS) line, 100 mm in length, ended with 2 verbal pain descriptor on either end one for each symptom extreme; "no pain" at the most left side of the line (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 /100-mm scale) on the rightest end

    Time frame: 15 mins

  2. Pressure pain threshold PPT

    pressure algometer ,The PPT represents a hybrid test, falling somewhere between self-reported paper-and-pencil type tools and objective diagnostic techniques

    Time frame: 30 mins

  3. function

    Neck Disability Index (NDI) This index consists of ten sections, including seven sections related to activities of daily living, two sections related to pain, and one section related to concentration. The score for each section is from 0 to 5, with 0 representing the highest level of function and 5 representing the lowest level of function. Total NDI-TH scores are shown as a percentage. A high score corresponds to a higher degree of disability. The internal consistency of the NDI-TH is high.

    Time frame: 15 mins

  4. Range of motion

    Cervical range of motion device (CROM) The CROM device is a reliable outcome tool for measuring upper cervical rotation. The clinical implications of these findings suggest that therapists can utilize the CROM device to more completely examine all planes of upper and full cervical mobility. It may also assist in identifying upper cervical ROM limitations associated with underlying cervical pathology or motion dysfunction

    Time frame: 30 mins

  5. postural stability

    Biodex Balance System (BBS) The Biodex balance system (BBS) uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously, which permits three measures to be obtained: an overall stability index (OSI), an anterior-posterior stability index (APSI), and a medial-lateral stability index (MLSI) will measure OSI ,APSI ,and MLSI

    Time frame: 30 mins

07

Study locations

1 site
  • Misr University For Science and Technology
    El-Sheikh Zayed City, Giza Governorate 3236101, Egypt
08

References and documents

Publications

  • Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w. PubMed 32723399 ↗
  • Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89. PubMed 17369782 ↗
  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615. PubMed 28826164 ↗
  • Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5. PubMed 28870191 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Mar 2022, 3 months.

Of 690 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 3 months is below that.

Counting every sponsor, half of 698 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2021
First posted
Sep 29, 2021
StartActual
Dec 1, 2021
Primary completionActual
Mar 1, 2022
CompletionActual
Apr 1, 2022
Last update
Sep 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05061121
Lead sponsor
Cairo University
Responsible party
Amal Ahmed Mohamed Morsi Abdel-Baky (Principal Investigator, Cairo University) — Principal investigator
First posted
Sep 29, 2021
Start date
Dec 1, 2021
Primary completion
Mar 1, 2022
Completion
Apr 1, 2022
Last update
Sep 7, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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